In general, one of the biggest differences between those defending science-based medicine and those defending pseudoscience, quackery, and anti-science is that science inculcates in its adherents a culture of free and open debate. In marked contrast, those advocating pseudoscience tend to cultivate cultures of the echo chamber. Examples abound and include discussion forums devoted to “alternative” medicine like CureZone, where never is heard a discouraging word–because anyone expressing too much skepticism about the prevailing view on such forums invariably finds himself first shunned and then booted from the forum. In marked contrast, on skeptical forums, almost anything goes. True, the occasional supporter of woo who finds his way onto a skeptical forum will face a lot of criticism, some of it brutal. However, rarely will he be banned, unless there are other reasons, such as insulting or abusive behavior. Such people may annoy the hell out of us sometimes, but on the other hand, they challenge us to defend our science and prevent us from becoming too complacent. Indeed, that’s what I like about skeptics. Nothing or no one is sacred. Not even James Randi. Not even Richard Dawkins. Not even Orac. (Ha! How’s that for an inflated sense of ego, mentioning Orac in the same breath as James Randi and Richard Dawkins? But, hey, it’s consistent with the character.)

In marked contrast, supporters of pseudoscience are very much characterized by their aversion to scientific debate. The reason is obvious. They don’t have the goods. They can’t win on science, reason, and evidence. The result is that they often end up forming communities where never is heard a discouraging word. Indeed, Prometheus describes this phenomenon well as he’s seen it in “autism biomed” discussion forums:

If you have the opportunity, check in to one of the many “biomedically oriented” Internet groups and see what happens when somebody questions the idea that “biomed” can “recover” autistic children. At the least, they will be admonished – “Don’t stand in the way of other parents getting their children the help they need!”. More likely, they will be told to “Shut up!” and banned from the group. In some cases, they will be harassed and even threatened.

This is not the first time an anti-vaccine activist has sued Dr. Offit. Just last year, Handley sued Dr. Paul Offit for a passage in his 2008 book Autism’s False Prophets, which included highly unflattering portraits (and, in my opinion, justifiably so) of anti-vaccinationists like Mr. Handley, including a discussion of a threatening post by Handley posted to an anti-vaccine mailing list, in which he said to the “neurodiverse folks monitoring this list”:

We will bring the full resources of myself and Generation Rescue to stop this. We will sue you for libel and we will go after your homes and assets. My lawyers live to investigate and sue people like you.

This, of course, sums up the attitude of all too many anti-science activists. They can’t win on the science; so they try to suppress criticism through legal action. It’s their most potent weapon. Even in the relatively defendant-friendly U.S., libel suits can be so intimidating that they will effectively silence criticism.

I don’t know enough of the details of the suit to determine whether Handley’s case had any merit or not, and I’m not a lawyer anyway. I tend to doubt it had any merit. However, I am pretty sure I have deduced Handley’s intent, as his e-mail and postings on AoA certainly leave no doubt as to his attitude. I also know that it’s very interesting that, as Squillo points out, Handley’s lawsuit was not filed on the basis of libel, but rather on “false light invasion of privacy” rather than for libel (a form of defamation), probably because false light is less well defined than libel and easier to prevail, perhaps as a result of Dr. Offit’s lawyer’s response. Whatever the case, Dr. Offit and his lawyers decided to settle rather than fight, with the settlement being an apology, an agreement to correct the passage in dispute, and a $5,000 donation to one of Jenny McCarthy’s favored autism charities, all of which to me sounds very much like a very minor settlement–a token. My guess is that Dr. Offit just didn’t want to go through the pain of a full trial, which is, of course, the point of such legal actions. My further guess is that Handley may have had just enough of a case plus a set of pockets deep enough to make a lot of trouble but probably not a good enough case to have had a high likelihood of prevailing if it had gone to trial. Otherwise, given his visceral hatred of Dr. Offit I highly doubt that Handley’ would have agreed to what is in essence a tiny token settlement. He would have wanted to make Dr. Offit bleed, if he could. On the other hand, Offit’s settling is a huge propaganda victory for Handley, which he has been trumpeting on his blog, and another possibility to be considered is that Handley didn’t really want Generation Rescue and himself to be subject to discovery.

Unfortunately, Handley’s apparent success appears to have emboldened other anti-vaccine activists, and this, I suspect, is why Ms. Fisher likely decided that she might be able to cause Dr. Offit some trouble. So cause him trouble she did by suing over this passage from Amy Wallace’s article:

Paul Offit has a slightly nasal voice and a forceful delivery that conspire to make him sound remarkably like Hawkeye Pierce, the cantankerous doctor played by Alan Alda on the TV series M*A*S*H. As a young man, Offit was a big fan of the show (though he felt then, and does now, that Hawkeye was “much cooler than me”). Offit is quick-witted, funny, and — despite a generally mild-mannered mien — sometimes so assertive as to seem brash. “Scientists, bound only by reason, are society’s true anarchists,” he has written — and he clearly sees himself as one. “Kaflooey theories” make him crazy, especially if they catch on. Fisher, who has long been the media’s go-to interview for what some in the autism arena call “parents rights,” makes him particularly nuts, as in “You just want to scream.” The reason? “She lies,” he says flatly.

“Barbara Loe Fisher inflames people against me. And wrongly. I’m in this for the same reason she is. I care about kids. Does she think Merck is paying me to speak about vaccines? Is that the logic?” he asks, exasperated. (Merck is doing no such thing). But when it comes to mandating vaccinations, Offit says, Fisher is right about him: He is an adamant supporter.

Regular readers may have noticed that I rarely, if ever, accuse anyone of lying. The reason is that I tend to believe that most anti-vaccine activists really and truly believe in their pseudoscience. Consequently, when they spread misinformation and outright nonsense, they are not technically lying, at least not most of the time, because they have no clue that what they are saying is false. Indeed, although I do not know the specifics upon which Dr. Offit based his claim that Loe Fisher “lies” (although having read some of her attacks on him I can certainly understand why he might come to that conclusion), I do know that she is profoundly wrong about the science of vaccines and, utterly impervious to science contradicting her viewpoint, spreads misinformation. Of course, whether Loe Fisher believes what she says or knows it to be false almost becomes a moot point when so much egregious misinformation and pseudoscience is spread against the backdrop of mountains of evidence showing that they are not scientifically valid. The end effect is more or less the same anyway. Even so, I choked on my iced tea when I read some of the passages in the complaint. In my estimation, Barbara Loe Fisher takes Jenny McCarthy’s disingenuous claim that she is “not anti-vaccine, but pro-safe vaccine” to whole new heights of bizarre contortion. I’ve written about this technique before. Fisher is very clever and couches her views in rhetoric of freedom and “informed consent.” Yet, it is very clear from the NVIC website what its true agenda is. For instance, there is a “memorial” for “vaccine victims,” which states:

They are the men, women, and children who have died or been injured by vaccines in nations around the world for the past 200 years. This is a virtual Memorial dedicated to those whose lives have been forever changed by vaccines they were often required by law to use.

And concludes:

Our hope is that, by honoring those who are casualties of mass vaccination policies, there will be greater public awareness of the need to value and care as much about those who are harmed by the complications of vaccines as we care about those who are harmed by the complications of infectious diseases. This International Memorial for Vaccine Victims is offered to the world as testimony of the need to protect the biological integrity of life on this planet.

The NVIC also runs a website called Stand Up! Be Counted!, which states: “No Forced Vaccination. Not in America.” It also makes common uses common anti-vaccine tropes, such as confusing correlation with causation for the “autism epidemic.” Meanwhile the NVIC page about the H1N1 vaccine cites dubious studies on mercury in vaccines, in particular the discredited Hewitson study that I blogged about here and here. Then there’s the Vaccine Law Firm Directory she maintains of lawyers ready to sue for vaccine injury. But perhaps most telling of all is the recent NVIC conference, in which luminaries of the anti-vaccine fringe presented their views and “data”, and in which the man who started the fear that the MMR vaccine causes autism based on the shoddiest of science, Andrew Wakefield and whom Barbara Loe Fisher herself has vociferously defended was given an award. The conference also included total cranks such as Gary Null, who is anti-vaccine to the core, an HIV/AIDS denialist, coffee enema advocate, and supporter of cancer quackery, and David Ayoub, whose claim to fame is that he thinks that mass vaccination programs are a plot by the Illuminati, complete with black helicopters. Quite frankly, from my point of view, if Barbara Loe Fisher really isn’t anti-vaccine, she sure as hell has an amazingly funny way of showing it. It would be very interesting to ask her whether there is anything or any evidence that could ever persuade her that vaccination is far safer than the diseases vaccinated against. I tend to doubt it, although I have no doubt, given her silver tongue, that she’d dance around the question quite skillfully, move the goal posts, or propose impossible-to-meet (in the real world, at least) standard of evidence.

My guess is that Loe Fisher’s lawsuit has very little to do with her reputation. After all, among real scientists knowledgeable about vaccination (as opposed to “scientists” like Andrew Wakefield) her reputation is–as Mike Myers would say–crap. Moreover, among Loe Fisher’s core constituency, I highly doubt that Dr. Offit’s saying “she lies” about her would have one whit of an effect on its opinion of her veracity, other than, perhaps, to make them love and believe her all the more. After all, in the circles that she travels, Dr. Offit is viewed as the Dark Lord of Vaccination, practically akin to Satan himself. To Loe Fisher’s fans, being called a liar by Paul Offit is probably every bit as much of a badge of honor as I consider being called names by J.B. Handley–or Barbara Loe Fisher, come to think of it, if she ever were to call me a liar. However, having her veracity called into doubt by a real vaccine scientist does hurt Loe Fisher in her efforts to win mainstream acceptance, and that is probably the real concern driving the lawsuit. (Well, that and to try to harass and intimidate Dr. Offit.) In any case, as Robert Carroll put it, Fisher is “very good at combining accurate information with misleading claims to give the impression that the risk of serious negative effects from vaccines is significantly greater than the risk of serious ill effects from the diseases they protect against.”

Another reason that Fisher’s frequent, impassioned, indignant denials that she is anti-vaccine are hard to believe is that she is very one-sided in her application of her appeals to freedom. She states over and over again that she is for “informed consent” and the right of parents to express “philosophical examptions.” No doubt a libertarian argument could be made on political and philosophical grounds for such a position. But, as blog bud PalMD shows, when a private institution chooses vaccination and decides that it will require vaccination before children can attend school, suddenly Fisher isn’t so down with the freedom thing anymore. For example, when a Jewish school in Pittsburgh decided that it would not accept philosphical exemptions and would require a letter from a child’s primary care physician in order to grant a medical exemption, Fisher was most displeased:

According to Loe Fisher, the federal vaccine injury compensation program, established by the National Childhood Vaccine Injury Act of 1986, has paid more than $2 billion to families of children who have been injured or died as a result of vaccination.

“Vaccination should not be separated out from the informed consent paradigm,” she said.

Since the establishment of the CDC and American Academy of Pediatrics recommendations regarding vaccination requirements, Loe Fisher continued, families seeking medical exemption from vaccination have found it rough going.

Because it’s hard for a family to find a physician to provide a medical exemption, Loe Fisher said, many must rely on the religious or philosophical exemption, available in almost all states, to avoid vaccination.

She is not in favor of a private school refusing to accept those exemptions which are provided for by state law.

“It is questionable for a school to narrow those exemptions and not allow a parent who believes a child is at risk to take an exemption,” Loe Fisher said.

In other words, Fisher is against the government mandating vaccination before a child can attend school, public or private, but if the administration of a private school voluntarily decides without government laws or pressure that it is going to require vaccination of its students before admission, she thinks that the government should have the power to enforce philosophical vaccine exemptions on it. Pretty one-sided of her, don’t you think? After all, I bet Loe Fisher supports the right of private schools, such as Waldorf Schools, that do not require vaccination, often have high percentages of unvaccinated children, and, of late, have become incubators for outbreaks of vaccine-preventable diseases, not to require vaccination of their students. Her support for “vaccine choice” except when it is the choice of a private institution to mandate vaccines casts her assertion in her complaint that she “does not seek to prohibit or advise against vaccination but to ensure that vaccination is voluntary and that it proceeds following fully informed consent” in a rather dubious light and contributes to the overall impression that she is in reality an anti-vaccine activist, not a “vaccine safety” activist.

In my opinion, after having read her website and seen her quoted in many interviews, the bottom line is that Barbara Loe Fisher is anti-vaccine. True, she’s good at cloaking what I consider to be her anti-vaccine views in rhetoric of “freedom” and “informed consent,” but whenever push comes to shove, she’s against vaccines and clearly thinks that they do more harm than good. Nowhere have I ever seen her say that she supports a single vaccination as routine. Not one. Her entire organization supports the scientifically discredited notion that vaccines cause autism and holds conferences with anti-vaccine speakers. It’s hard not to conclude from this that she is anti-vaccine. Moreover, Barbara Loe Fisher is one to talk about libel, after what she said about Dr. Offit the very article by Amy Wallace over which she is suing:

Against this backdrop, Fisher, a skilled debater who often faces down articulate, well-informed scientists on live TV, mentioned Offit frequently. She called him the leading “pro-forced-vaccination proponent” and cast him as a man who walks in lockstep with the pharmaceutical companies and demonizes caring parents.

Maybe Dr. Offit should countersue for libel. It sounds as though he may have a case.

Be that as it may, it is important to remember this. Just like those of the Society of Homeopaths, “Dr.” Obi, the British Chiropractors Association against Simon Singh, or Matthias Rath against Ben Goldacre, Loe Fisher’s lawsuit is also likely far more about shutting up critics than it is about protecting her reputation. Clearly, Wallace’s article hurt the anti-vaccine movement. Moreover, if there’s one good thing about 2009, it’s that more and more mainstream media outlets stopped portraying the anti-vaccine movement as poor, persecuted parents and more and more portrayed it as a threat to public health based on pseudoscience, which it is. Yes, it’s true that individual stories from the movement can be very sad and compelling; many of these parents and their children have had a horribly rough time. However, we do not have to downplay their difficulties or insult them personally to point out that they are profoundly wrong based on science when they blame vaccines for their children’s autism and that their activities do represent a serious threat to public health. More and more reporters, like Trine Tsouderos, have come to realize that. They represent a threat. Moreover, demonizing these journalists online, as the anti-vaccine movement tried to do with Amy Wallace and Trine Tsouderos, doesn’t work very well. That leaves lawsuits to intimidate those who would speak out and discourage other media outlets from writing similar stories.

I wonder…Sense About Science did a fantastic job of publicizing the Simon Singh libel case and using it to promote the need for reforming the U.K.’s libel laws. I wonder if it’s time for a similar movement right here in the U.S. to prevent promoters of pseudoscience from using the law to intimidate and harass defenders of science-based medicine. Although Dr. Offit probably has the financial means to defend himself, there are a lot of writers and bloggers who do not, should someone with deep pockets decide to try to silence them with a frivolous lawsuit. We definitely have a problem here, and I predict it’s going to get worse as pseudoscience movements like the anti-vaccine movement rightly become more and more marginalized.

ADDENDUM:Autism News Beat, Steve Novella, and Terra Sigillata have more. ANB and Steve Novella, in particular, list all the misinformation that Barbara Loe Fisher has spread in the name of demonizing vaccines, such as the claim that the DTAP vaccine causes sudden infant death syndrome (SIDS), when, if anything, the evidence suggests that it is probably protective, and her deceptive fear-mongering about squalene adjuvants in the H1N1 vaccine (which, by the way, the H1N1 vaccine doesn’t contain).

The discrimination begins, always, with the majority in a society pointing the finger at a minority for somehow endangering the public health and welfare. Individuals in the minority group are singled out as different – ethnically, biologically, spiritually, morally – from the majority. The human impulse to fear, judge, marginalize or eliminate those different from the rest has left a blood soaked trail winding throughout the entire history of man from the Great Inquisition to the Holocaust; from the killing fields of Cambodia to Rwanda, Serbia and Tibet; while the persecution of those with leprosy, TB, AIDS, mental illness, and handicaps continues in every society.

Later in the same article, I found this quote by Loe Fisher:

Holocaust survivor Elie Weisel has said “When you take an idea or a concept and turn it into an abstraction, that opens the way to take human beings and turn them, also, into abstractions.”

Individuals harmed by vaccines are not abstractions. They are human beings who deserve to be spared a lifetime of suffering rather than being thrown under the bus to prop up forced mass vaccination policies that fail to acknowledge biodiversity within the family of man.

Geez, was Barbara Loe Fisher really comparing criticism of the anti-vaccine movement by defenders of science-based medicine to what the Nazis did to the Jews during the Holocaust? Where’s the Hitler Zombie when you need him? Clearly, her brains have been chomped by the Undead FÃ¼hrer. Her hyperbole in rhetoric against defenders of mass vaccination programs also strongly belies her denial of being “anti-vaccine.”

This is a copypaste of a post I left on the National Vaccine Information Center facebook page. Yes, Barbara Loe Fisher is certainly not anti-vax:

“”If the State can tag, track down and force citizens against their will be injected with biologicals of unknown toxicity today,there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.” â Barbara Loe Fisher, Co-Founder NVIC

Talk about a slippery slope based on a false premise. Wow! This stuff is straight out of the Icke manual for “run for the hills, the lizards are coming!”

Thanks for the analysis Orac, I completely agree that these lawsuits are intended to shut down supporters of science-based medicine. I hope that Amy and Paul will show the same courage and tenacity that Simon Singh has shown, and show up the anti-vaccination brigade for the bullies (and wackjobs) that they really are. Simon’s decision to stand up to the legal thuggary of the British Chiropractic Association has done far more damage to their reputation than his original article over which they sued would ever have done. All you have to do to see this is do a google search on “British chiropractic Association”.

”Oh, them,” said Barbara Loe Fisher of Washington, referring to the experts, adding, ”They have been attacking parents who have been talking about vaccine safety concerns.” … ”I am not anti-vaccine,” Ms. Fisher said. ”We believe a humane vaccination and health policy should be in place. We are against forced vaccination.’

“That science has not been done, because those who hold the money in this country for research, government and the pharmaceutical industry, are not allowing those studies to be conducted,” says Fisher.

I saw this on the Millenium Project this morning. I am glad you wrote about it also.

Funny thing, I didn’t even know about this Wired article before I heard about this law suit (read it, great story). I hope Ms. Fisher has inadvertently caused more attention to be brought to this article.

Seems to be on the internet there is no bad publicity. People will read this article wondering what the big deal is. If just a few of these people get Dr. Offit’s message because of this, it will all be worth the trouble.

I personally have a favorite quote from Dr. Offit:

âWhat I loved about science was its reason. You have data. You stand back and you discuss the strengths and weaknesses of that data. Thereâs just something very calming about that,â he says. âYou formulate a hypothesis, you establish burdens of proof, you subject your hypothesis to rigorous testing. Youâve got 20 pieces of a 1,000-piece puzzle â¦ Itâs beautiful, really.â

Offit represents and presents passionless science and truth. Because it doesn’t go their way, and because he is an esteemed scientist, Paul Offit scares Handley, Fisher, and their merry little, but loud, band of antivax extremists. The freaks making up this little rabble are really one step removed from Ted Kaczynski. We should be thankful that they sic lawyers on Offit, reporters, and bloggers because if they took a step the other way, moved to a shack in Idaho, and “got even” from there, things would be much worse for all involved.

Well. well, well when will it ever end? Why is it if there’s something I don’t like about vaccines all hell lets loose? Why am I an anti-vaccinationist if I want to have my say?

What bothers me is exactly where all these bile driven persons are coming from. Isn’t it true that Dr Paul Offit a US Government advisor on vaccines has made some millions of dollars from vaccine? Should he really advise on vaccine safety?

Here are some UK facts for you; A research study published in Pulse the medical profession journal in Nov 2002 reported that a 2002 study of 29,000 school age children in Cumbria UK found fourteen times more allergies, asthma and psoriasis in vaccinated kids than in unvaccinated.

My own stringent ad hoc research as a non scientist has failed to find (out of three million individuals) any single example of an autistic person. Like the Amish, like the Homefirst community there are no autistic people in Britains unvaccinated.

As for the States, since you vaccinate kids out of sight in your country it’s not surpising that you cannot see that the unvaccinated ones are not autistic! It’s not science it is arithmetic. I am quite good at arithmetic why aren’t you?

Additional recent delusion-based legal actions:1.May 2009- Celia Farber,vanity-journalist and HIV/AIDS denialist,sues a doctor,a law student, and the director of a non-profit(TAG),who disagreed with her brand of reality(this suit’s time limit has run out).2.October 2009-Null(who has 7 lawyers**)sued NY state and the FDA about mandatory H1N1 vaccination and supposed safety issues surrounding it.Although these actions have yet to go anywhere,they have generated several “hard-hitting”,”impassioned” videos(see website).Reportedly, the “Quackbusters”(sic) are next…I see these lawsuits as publicity-mongering as well as an attempt the placate the mar…uh,..the *adherents* who are usually being promised a “great over-turning” of “orthodox” medicine which should be forthcoming. **(Why would *anyone* need 7 lawyers?)

My own stringent ad hoc research as a non scientist has failed to find (out of three million individuals) any single example of an autistic person. Like the Amish, like the Homefirst community there are no autistic people in Britains unvaccinated.

In any case, you’re spouting nonsense. There are autistic Amish. This has been shown time and time again, and HomeFirst has never published its results that I’m aware of. Sure, Dr. Eisenstein makes that claim frequently in the press (and I don’t think that even he claims there are “no” autistic children in his practice who are unvaccinated), but he won’t put his money where his mouth is and try to publish it in a peer-reviewed journal.

What bothers me is exactly where all these bile driven persons are coming from. Isn’t it true that Dr Paul Offit a US Government advisor on vaccines has made some millions of dollars from vaccine? Should he really advise on vaccine safety?

Gee, experts on a subject being asked to advise upon it? What a strange idea!

Here are some UK facts for you; A research study published in Pulse the medical profession journal in Nov 2002 reported that a 2002 study of 29,000 school age children in Cumbria UK found fourteen times more allergies, asthma and psoriasis in vaccinated kids than in unvaccinated.

Got a more precise citation? I find nothing matching this description in a PubMed search for “cumbria”, and “cumbria vaccinated” turns up one article that’s definitely not the one you mention.

Also, any effect of such a size would be trivially easy to observe in any number of studies – so where’s the pile of followups?

My own stringent ad hoc research as a non scientist has failed to find (out of three million individuals) any single example of an autistic person. Like the Amish, like the Homefirst community there are no autistic people in Britains unvaccinated.

There are autistic Amish (and the Amish DO vaccinate; that entire claim is a straight-up lie). The Homefirst stuff is unsubstantiated garbage. And your “own stringent ad hoc research” is meaningless without all the relevant details. Claiming to have numbers for 3M individuals is particularly suspicious – where did you get the data to make such statements?

As for the States, since you vaccinate kids out of sight in your country it’s not surpising that you cannot see that the unvaccinated ones are not autistic!

There are autistic unvaccinated children; this is well-documented.

It’s not science it is arithmetic. I am quite good at arithmetic why aren’t you?

Just to reiterate a point Scott makes, IF it were actually true that Offit is a government adviser on vaccines, it’s hard to see why that is necessarily a problem. If he were, it would be because he is an expert on vaccines. You gotta wonder, who else would you want advising the government on vaccines but an expert?

Being an “government adviser” does not make one an expert, one has to be an expert first.

Similarly, while it is true that Offit developed a vaccine, you have to ask the question, does he support vaccination because he developed a vaccine, or did he develop the vaccine because he believes vaccination is an effective health measure?

Just saying, “Offit profits from vaccine” does not necessarily impeach his view.

I hate to say this, given I am not the one facing the firing squad, but Offit messed up by settling that lawsuit, particularly without keeping the terms of it confidential. It emboldened his detractors and now they’re going to make open season on him.

Because your ‘say’ consists of a big heap of many-times-debunked distortions and lies, with a side order of unfounded character smears and conspiracy theory thrown in for reinforcement. If you can’t be intellectually honest with yourself, why should anyone else expect you to treat them any better?

I am quite good at arithmetic why aren’t you?

My high school math teacher taught us that the most important thing wasn’t providing an answer, it was being able to show exactly how you arrived at it. Because if your working is bullshit, it doesn’t matter what your conclusion was – it’s wrong anyway.

After looking at the complaint, and rereading the relevant section of the article, I kind of have to conclude that Fisher actually may have a reasonable case here.

The key phrase in the article that she’s suing over is, as I read the complaint, “she lies”. That’s followed by, and appears to be a reference to:

Barbara Loe Fisher inflames people against me. And wrongly. Iâm in this for the same reason she is. I care about kids. Does she think Merck is paying me to speak about vaccines? Is that the logic?

But, um, that doesn’t constitute lying unless she KNOWS such statements to be untrue. Even if we take “she lies” to be more general, he’d need to be able to show that she lied about something to make such a statement legitimate. It’s uncannily similar to the Singh situation, really – the alleged libel is a claim of deliberate falsehood. But Singh didn’t really make such a claim, while Offit did.

What I’m unclear on, not being a lawyer, is what Fisher’s burden of proof would be. Would she have to prove that Offit didn’t genuinely believe that she didn’t genuinely believe what she was saying? (i.e. that he didn’t truly think she was lying as opposed to mistaken) Or would it be enough to show that she really does believe what she says?

It’s only a lie if she knows that the US H1N1 vaccine contains no squalene. If she heard a bunch of people she likes claim it does, and it fit her preconceptions so she accepted the statement uncritically and repeated it, then she’s mistaken and gullible, but not lying in the usual sense of the word.

There is more to lying than simply telling a falsehood and knowing it to be false. There is also lie by omission, e.g., touting Andrew Wakefield’s work without stating anything about subsequent developments. Or knowingly citing some early study that supports her position, but not informing readers about more recent studies that show the earlier one to be false. There is also the contextual lie: in essence cherry picking a portion of text so that, out of context, its message is different than the greater context.

If there is something that she presents as truth, without knowing for certain whether it is true or not, well, that’s a fabrication, another type of lie.

However, the type of lie she may most likely be guilty of would be dissembling, or presenting something that, while technically not an outright lie, has the purpose of getting someone to believe an untruth.

So, there are probably a number of angles that could be used to defend against a libel suit based solely on “She lies.”

In fact, I found this bit on NVIC:

Offit’s attempt to exonerate DPT is part of a larger effort to convince the public – and drug company stockholders – that most vaccines, including his own, have no risks whatsoever.

It could probably be shown that trying to “convince the public…that most vaccines…have no risks whatsoever” is demonstrably false and misleading. In fact, the page I got that from has numerous tidbits of mischaracterization.

The strange question always gets posed: should the government seek out Dr. Offit’s advice on vaccines.

Let’s see, he’s a trained infectious disease specialist who went through the process of not only inventing a vaccine, but of also helping a company develop the vaccine into a viable product. (Anyone who thinks that the development part was at all straightforward has zero understanding of R&D).

Are we supposed to take as our experts people with no specialized training? People who never studied the field in depth?

In autism the answer is all too often “yes”. They are called DAN doctors. Or, worse yet, we are supposed to take our advice from MBA’s and other unqualified lay people.

Good points, Todd. Her case is weaker than I was thinking, in that light. (Though still much stronger than that against Singh.) If there are any lawyers in the crowd, I’d be quite interested to know their opinions!

You can relax. The public figure and public concern doctrines will put a couple of difficult burdens of proof on BLF. I’m more worried that they might be able to make enough claims to survive summary judgment and get to a jury, simply because that would be expensive.

Roughly, BLF has to prove that it is more likely than not that the statement is false and that Dr. Offit was acting maliciously – he knew the statement to be false, or made it without caring whether it was true or not. Since that’s essentially an opinion, the burden would be on her to prove that there isn’t enough information out there for Dr. Offit to reasonably conclude she was a liar.

As for Orac’s comment about false light – yes, its broader than traditional libel. Most notably, misleading, but truthful, statements can trigger the tort of false light. The most commonly cited example of this was when Playgirl magazine’s cover said that there would be 12 nude guys in the magazine in a way that implied the cover model was one of them. He wasn’t, sued, and won.

The most commonly cited example of this was when Playgirl magazine’s cover said that there would be 12 nude guys in the magazine in a way that implied the cover model was one of them. He wasn’t, sued, and won.
————-
When was Paul Offit in Playgirl?

The two Supreme Court cases to look at are New York Times Co. v. Sullivan (requiring proof of malice) and Philadelphia Newspapers, Inc. v. Hepps (requiring plaintiffs to prove that the statement was false if it is on an issue of public concern).

Isn’t it true that Dr Paul Offit a US Government advisor on vaccines has made some millions of dollars from vaccine? Should he really advise on vaccine safety?

Longer answer since I am not running out the door, which I will answer with a question. Do you see his name on this list?

Yes, he was a member of that that advisory committee when RotaShield was approved in 1998. But by the time it was time to approve RotaTeq, he was not on the committee. Here are the February 2005 ACIP Minutes, where RotaTeq is discussed. Go to the 77th page of the pdf file, is Dr. Offit listed as a member? He was a participant, when down at the bottom. He is listed as a member of the public or presenter (I am placing bets as a presenter), but he was definitely not a voting member.

This stuff is so easy to check. Why would anyone keep claiming he voted for the vaccine he helped develop long after he was off the committee?

So, if these folks can file frivolous lawsuits against people with scientific facts on their side, why doesn’t anyone sue The Psychics Network, or that guy who wrote the book about ‘secrets THEY don’t want you to know’ or ‘Sharks don’t get cancer’ [but actually they do]? Or have they been sued?

Actually, Kevin Trudeau, the author of such works of luminary scholarship as “X THEY Don’t Want You to Know”, has been in hot water, repeatedly, with the FTC for making false and fraudulent claims. Every time, he just switches genres slightly (e.g., natural cures to economics).

I believe the guy who wrote the Secrets book may actually be currently sued by several people due to the deadly sweat lodge incident. And I remember reading over a decade ago that Miss Cleo of the Psychic Network was sued, but I don’t know what happened.

The FDA is constantly going after scammers, including the Kevin Trudeau… but they keep popping back.

From the complaint: “Defendant Offit’s accusation that Plaintiff Fisher “lies” is false and defamatory. It is made with common law malice – spite and ill will. It is also made with actual malice – reckless disregard of the truth and/or knowing falsity. Offit, a man of sophistication versed in evaluation of scientific proof, knows the statement to be false because he lacks facts necessary to confirm it.”

I wonder whether this line in there is meant to suggest that Barbara Loe Fisher is simply not good enough at reasoning to know that she is uttering falsehoods.

A research study published in Pulse the medical profession journal in Nov 2002 reported that a 2002 study of 29,000 school age children in Cumbria UK found fourteen times more allergies, asthma and psoriasis in vaccinated kids than in unvaccinated.

Did this “study” prove causation, or just correlation? Here’s an alternative explanation: the unvaccinated kids happened to be in the rural boondocks, and thus had much more consistent exposure to nature than kids in cities and suburbs; and — as many actual pediatricians and allergists seem to agree these days — that consistent exposure primes the kids’ immune systems to respond more sensibly to what we city folk call “allergens.”

PS: I notice you didn’t give a citation for this study. I also notice you didn’t come back to defend any of your statements after they were debunked here. Can we take that as an admission that you’ve lost this argument?

Irony: writing a post about “suppression of speech through legal intimidation” without once mentioning the FDA, which has spent literally billions of dollars on silencing and penalizing non-corporate cures. Attacking a handful of libel suits while ignoring how your side routinely fines and arrests unconventional medical pioneers (like Kevin Trudeau, or the late Dr. Hulda Clark, who was forced to flee to Mexico because of constant persecution and harassment by the U.S. government) seems like a very large kettle criticizing the color of a very small pot.

The researchers said although the study found a link between the vaccines and asthma, it was ‘unlikely’ to be causal.
The cohort study compared doctor-diagnosed asthma and eczema rates in unvaccinated children with those immunised against diphtheria, polio, pertussis, tetanus and MMR.

and…

Study co-author Dr Richard Hubbard, senior lecturer in respiratory medicine at the University of Nottingham, played down the findings, arguing there were ‘significant interactions’ between vaccination and consulting behaviour.
He said: ‘The problem is people who don’t go to the doctor’s don’t get diagnoses of asthma and don’t get vaccinated. In the unvaccinated group you will always see a lower risk of asthma.’

and….

Dr Chris Cates, editor of the Cochrane Airways Group and a GP in Bushey, Hert-fordshire, said that he was unaware of any previous link between vaccinations and asthma.
He added: ‘What I would not do is say this proves that vaccination causes asthma. Trying to untangle whether vaccinations have a role in this is incredibly difficult.
‘If people consult more they are more likely to get diagnosed.’

And no, the “work” does not appear to have made it into peer review. All we have is a magazine article, which the authors and commentators agree actually shows no evidence of causal association.

So Mr Bateson, all you have shown is your propensity to cherrypick quotes and work that might support your position. Scientifically literate? No you are not. A liar? Well, I’ll leave that for others to judge.

If you like this story, you’ll love the story of Siobhan Reynolds. She’s an advocate for pain patients, and she’s being persecuted by a federal prosecutor who doesn’t like the fact that she’s giving the public accurate information about the necessity of pain treatment, making it more difficult for the government to jail doctors who are trying to provide adequate pain medication to their patients.

FDA, which has spent literally billions of dollars on silencing and penalizing non-corporate cures. … (like Kevin Trudeau, or the late Dr. Hulda Clark, who was forced to flee to Mexico because of constant persecution and harassment by the U.S. government)

Honestly, I cannot tell if that is sarcasm, but I’ll bite.

Sure, mad, and I bet you would be the first person wanting to prosecute the gas station that put a special fuel in its pumps made entirely of dihydrogen monoxide. Sure, you believed that it was going to work in your car just fine, until you tried to drive more than a few feet.

By the way, there is a difference between accusing a person of lying, and actually committing fraud. Did you really think Hulda Clark when she said the cause of all diseases was the Fasciolopsis buski? How gullible are you?

“My own stringent ad hoc research as a non scientist has failed to find (out of three million individuals) any single example of an autistic person. Like the Amish, like the Homefirst community there are no autistic people in Britains [sic] unvaccinated.”

After parsing out all of the clauses, this claim boils down to:

“There are no autistic people in Britain who are unvaccinated.”

I don’t know if this is true in Britain, but it is not true in the US. There are a number of children with autism who were not vaccinated, often because they have an older sibling who is autistic.

But, even if Mr. Bateson’s “stringent” and “ad hoc” (his use of these words indicates he doesn’t know what they mean) research was unable to uncover a single autism person in Britain who was unvaccinated, that does not mean that vaccines cause autism.

The short explanation for this is that the percentage of the population – in Britain or the US – that is completely unvaccinated by the age of three years is very small – 0.6% in the US. Even if Mr. Bateson had personally examined “three million individuals” for autism and vaccination status, he would have found 30,000 autistic people (roughly) and only 180 of them would have been completely unvaccinated at age three years. Even fewer would have been unvaccinated by the time they reached school age.

Given that Mr. Bateson almost certainly did not examine “three million individuals”, it is not surprising that he failed to find an unvaccinated autistic person. An obvious question would be how many unvaccinated non-autistic people he found in his “research”.

I don’t expect an answer – I suspect that Mr. Bateson hasn’t done any research into autism or vaccination. However, if would care to share with us the details of his “research”, I’m sure that we would all find it illuminating.

Wow. Kinda crazy how much time you guys feel you need to spend on reaming people who have dedicated their lives to advocate for vaccine safety and the right to have informed consent on what is being injected into our and our children’s bloostreams.

I have yet to hear anything from you pro-vaccine pushers that offer any value to the real vaccine debate. If your goal is to get more people to buy into the massive one-size-fits-all vaccination program, then you seriously need to change your focus. We on the pro-vaccine safety side would like to hear some responses to the real argument at hand – the missing science.

Oh all knowing “science-bloggers”… please enlighten us with some of the missing science. I am sure you won’t be able to because even Paul Offit himself personally told me in a phone call that the data I am looking for does not exist…that there isn’t the money for it.

1. Long term studies (multiple please) of our vaccination program
2. Studies comparing health outcomes of vaccinated versus unvaccinated
3. Studies on combination of vaccines since that is how we give them
4. Studies that include real placeboes (not another vaccine)
5. Unbiased studies with independent researchers
AND last but not least
6. Studies on the possibility of vaccines causing autism.. (more than just one ingredient and one vaccine please)

It will be interesting to see if you choose to speak to this missing science or if it is handled in the same old manner. We are all waiting…

Anna, look up on the upper left side of this blog. You will see a box that is labeled “search.” Now go and put in the pertinent words in the box and hit enter. Then you will find the answers you seek (especially about the ethics of the vax versus unvax). Then go over to http://www.sciencebasedmedicine.org blog and do the same (though the search box is on the right side of the page).

This posting is about the libel case against Paul Offit by Barbara Loe Fisher, we have no reason to re-hash the more than five years of this blogs posting just for your entertainment.

Anna, if you actually read some of the post you may learn what is so incredibly wrong with your quote “and the right to have informed consent on what is being injected into our and our children’s bloostreams.”

So where did you learn that vaccines go into to blood?

You really have lots of education to catch up on, so get cracking on reading many of the older blog posts!

“Oh all knowing “science-bloggers”… please enlighten us with some of the missing science. I am sure you won’t be able to because even Paul Offit himself personally told me in a phone call that the data I am looking for does not exist…that there isn’t the money for it.”

What kind of tone is that if you truly came here for information.

You have spoken with Dr.Offit and he said the data you were looking for doesn’t exist? Putting aside the dubiousness of that claim; The studies you are asking for are unethical! There is plenty of evidence people like you are ignoring, because you already know it all.

There is no amount of evidence that will convince the anti-vaccine movement.

Dr Chris Cates, editor of the Cochrane Airways Group and a GP in Bushey, Hert-fordshire, said that he was unaware of any previous link between vaccinations and asthma
——————–
However, the [IOM]Committee also concluded that they did find some biological mechanism evidence that vaccines could increase the risk of immune dysfunction in some children that could lead to increased infections and allergy, including asthma.

The problem with Anna’s questions is that they have all been answered multiple times on this and other blogs. She got those questions not by being curious herself, but by cut and pasting the points made at Generation Rescue and Age of Autism.

It is like she walked into the last ten minutes of the play Hamlet, and starts loudly asking what is going on!

If she was truly interested in the answers she could start by checking out the critique of the Fourteen Studies on this blog and the multiple treatments it got at the ScienceBasedMedicine blog.

Oh, and T. Bruce McNeely, I almost think that “mad swine” is joking. Though I can never be sure, ten years ago I got a good dose of the insanity of Usenet when some woman tried to tell me that my son’s seizures were caused by someone on “stimulants” thinking about him! (see the Gail Michael FAQ)

Actually Sid, there is some weak evidence that links delays in vaccination with lower rates of asthma.

The antivax crew jump on this “headline” without bothering to read what the researchers say in their conclusions of these studies.

It appears that the kids who have delayed vaccination are the ones who seemed to have an intercurrent infection at the time the vaccine was due. And that infections and higher exposure rates to bacteria in childhood lead to slightly lower rates of asthma.

So the link is entirely spurious. But you wouldn’t care about that would you. You don’t care for any scientific evidence that challenges your cosy little “vaccines are evil” world view.

I couldn’t resist doing a little ball-park arithmetic to add some perspective to the figures reported in Pulse, which at first glance seem quite alarming. A total of 29,000 children were studied. Of these, 96% were vaccinated and 4% unvaccinated, which equates to 1160 unvaccinated children. The BMJ reports that 21% of British children have been diagnosed with asthma. So of the 1160 unvaccinated children, you would expect about 244 to have a diagnosis of asthma, but 14 times fewer than expected were actually found, which makes about 17. So there were around (244-17 =) 227 fewer children diagnosed with asthma in the unvaccinated group than you would expect. Cumbria is a largely rural county with the second lowest population density in England, so I don’t think it is at all unlikely that a couple of hundred wheezing children managed to avoid being both vaccinated and diagnosed with asthma out of a group of 29,000.

“Oh all knowing “science-bloggers”… please enlighten us with some of the missing science.”

I think one of the most illuminating things I have learned about science in the last year or two is that science isn’t really about saying that we know something with absolute certainty and total authority. (FWIW, that is more of a faith or religion based point of view.)

Science is really about placing bounds on and reducing our uncertainty. So, each study or experiment or analysis that we do as scientists does not give us the final, absolutely true and correct answer.

But, at least we hope, it gets us another half of the way to that true and correct answer.

I doubt if this is news to any science-blogger or even to most of the commenters on this blog.

However, in view of this concept, for anyone to think that they are an “all knowing science-blogger” would be a major oxymoron.

To be fair, Tony Bateson is the other side of the pond, he posted at what would have been his late afternoon, and it’s (now) about 0230 in London, so he’s probably asleep. Of course, if he is still acting like a pup this time tomorrow, I’d agree he’s just a one hit wonder, and ran off when he was spanked.

dt – were you able to find the article he mentioned? I found what I think is the site,http://www.pulsetoday.co.uk/ , but couldn’t find the article itself. I’d like to go back to the the UK some day, so I don’t want to say he made the whole story up, and maybe wind up in court myself… You don’t *say* your quotes above were from the article in question, but it was sorta implied – but I’m embarrassed to say I couldn’t find it. Link?

I should point out that I have encountered Tony Bateson in other forums, where he has claimed either that a) there is no such thing as an unvaccinated person with an ASD, or b) there is no such thing as an unvaccinated person with an ASD in Britain. I suspect that he switched from the former claim to the latter because he finally discovered the Generation Rescue phone survey which reported substantial numbers of unvaccinated people with ASDs, and is hoping no one will call him on the fact that an unvaccinated person with an ASD anywhere, not just in Britain, torpedoes his “arithmetic” that “unvaccinated [persons] are not autistic”.

Unfortunately, this was filed in Virginia and I don’t think that Virginia has an anti-SLAPP (Strategic Lawsuits Against Public Participation) law. Those laws are intended to help prevent this kind of thing.

Yeah, “entertainment”. That’s what I am looking for. Seriously? I would think you would welcome this as an opportunity to add sources for those reading who sincerely want answers, instead of directing me/others to your “search” field. If you want to talk entertainment…in my point of view that is exactly ALL this science blog is doing. Entertaining each other…not doing anything to assist the other side coming to your point of view. If you were really concerned about helping people come to your side, then you would take more time to directly respond to legitimate questions on here. The truth is you can’t respond directly because the science is not there. It has not been done. And what I don’t get is why people not only don’t care that there is missing science/answers, but they adamantly fight against getting these answers. Why!?! The most mind boggling to me… Are people really okay with the fact that only one vaccine has been studied in relation to Autism?

And pardon me for not choosing an appropriate enough blog post to discuss this missing science… where do you prefer I post it? I’d like to see some real discussion where attacks on people are not the main goal (this blog post being just another example of that). Attacking Barbara Loe Fischer for trying to protect her reputation so she can continue the fight for vaccine safety, informed consent, and higher quality/non-biased studies is nothing more than a waste of time and a great example of what this site is all about. Less about science and more about bashing others.

As far as “walking in during the last 10 minutes and loudly asking – what is going on?”. Let responses like these be a lessen to you readers… If you are not part of the science blog clan, don’t both posting anything. Outsiders and legitimate questions are not welcome here…this site is for one-sided thinkers only looking for a means of entertainment.

My guess is that this is just a publicity grab by Fisher, who has seen her status as the matron saint of anti-vaccine lunacy usurped by Jenny McCarthy. The NVIC used to be marginally relevant in the world of pro-disease wackiness, now that mantle clearly belongs to Generation Rescue.

People seem to forget that when the U.S. government wanted to resume smallpox vaccinations, Dr. Offit was against it because the risk of adverse reactions to that particular vaccine is far too high given the rarity of the disease. Incidentally, since smallpox was dropped from the schedule, the amount of toxins given in the entire vaccine schedule since 1980 has been about 4% (four percent) of what it was in the preceding century. So if vaccines are causing autism, autism should have vanished.

Also, Canada dropped the mercurochrome-type preservative from its vaccines ten years earlier than the U.S. did, without affecting the rate of autism diagnosis. So what’s your mechanism? Some studies are suggesting that autism is correlated with a lack of Vitamin D in one or both parents. If you are actually concerned with autism, you’ll follow up on that instead of continuing to bark up the wrong tree.

Are you saying you don’t know how to use the search option on a website? Your anti-vax friends will be so disappointed in your lack of mad google skillz.

Here’s a hint – repeating the lie that the autism/vaccine connection hasn’t been studied (or basically disproven) doesn’t make said lie true.

Another hint – Barbara Loe Fisher doesn’t want better studies. She wants people to be scared of vaccines, because as long as they’re scared of vaccines the NVIC exists. And as per their IRS forms, the NVIC is Fisher’s full-time job.

And this has nothing to do with the accusations that Barbara Low Fisher has plagued Dr. Paul Offit with. Look up thread. Was he on the ACIP committee when the RotaTeq vaccine was approved? I provided the links, look at them!

Now do try to figure out how to search the blogs yourself. Outsiders are quite welcome here, as long as they are willing to be educated.

Do I really need to explain my analogy to you? Okay, I shall:

1) Your questions are not new, they have been asked before (they regularly posted on places like Age of Autism, the Autism/Mercury Yahoo Group, Generation Rescue, the sMothering Commune and other common anti-vax forums).

2) Hamlet is a very commonly known play. It was written several hundred years ago by a famous playwright, William Shakespeare. Most well educated high school graduates are familiar with the play (even if you just saw the movie Hamlet 2, you would know everyone in the original play is dead at the end… oh, the last half of that movie is very good, the first half, not so much).

3) The last ten minutes of the play includes a very violent conclusion. It is full of speeches and sword fights, at the end of the play everyone on stage is dead (that is also true for the play about Julius Caesar, which I first saw on the live stage depicted as a Latin American banana republic, everyone dead on stage in jungle camoflage!).

4) Entering at the end of the play asking loudly what is going on when there is lots of action is rude and obnoxious. It shows that you have not even reviewed the Cliff Notes of the play (or this and other blogs for the answers that have already been given to your “questions), and not even bothered to come in on time. This is what you did demanding answers to questions that have been answered over the past several years (especially with the faux pas of saying vaccines were injected in the bloodstream!).

5) You barged in demanding we answer questions that have been answered multiple times before.

6) You did not even try to do research outside of your comfort zone. I tried to prod you to use the search function available, and you still want to be spoon fed the answers given over and over and over and over again. That is boring.

7) I am repeating myself because you seem to need that. You are very boring. Do try to fix that. Come up with something new.

Wow. Kinda crazy how much time you guys feel you need to spend on reaming people who have dedicated their lives to advocate for vaccine safety

Uhm. Who exactly has “dedicated their lives to advocating for vaccine safety”?

One of my votes would go to Paul Offit, M.D., who spent years of his life to developing safer and safer iterations of a vaccine against a disease that killed millions of infants.

Then there all those not-so-famous researchers who likewise dedicated their careers to developing ever-more-efficacious & ever-more-safe vaccines against common childhood illnesses that while common, had serious risks of disability and death

Exactly how many childhood deaths has Barbara Loe Fisher prevented? What is your evidence? Can you stack Ms. Fisher’s numbers up against the vaccinologists since Ms. Fisher began her campaign to re-introduce vaccine preventable disease?

I will respond to one of your questions:

Studies comparing health outcomes of vaccinated versus unvaccinated

The procedural and ethical issues surrounding a meaningful study of “vaccinated versus unvaccinated” have been addressed in a number of blog posts, which are easily found using a robust search engine.

As far as “walking in during the last 10 minutes and loudly asking – what is going on?”. Let responses like these be a lessen to you readers… If you are not part of the science blog clan, don’t both posting anything. Outsiders and legitimate questions are not welcome here…this site is for one-sided thinkers only looking for a means of entertainment.

This quote of yours vexed me to the point I had to go off, fold the last of the laundry, and think. I’m not a scientist. I’m just a mom (ok, a mom with a BA & an MBA &some other edu credits)…

But the point is, if you walk into a community, it is your responsibility to find out if your legitimate questions have been previously addressed.

Yes, your questions about vaccine safety are legitimate. But they have been addressed, previously and at length, both on this blog and elsewhere. The answers to your questions are easy to find.

Finally, Anna, I’d like to point out something. Over at the “vaccines cause autism” universe, people who don’t agree with that world-view aren’t represented at all. I know this for a fact, as none of my responses to posts at Age of Autism have ever been posted. However, I’ve been ridiculed by name there. My rebuttal wasn’t posted.

I would say that Ms Fisher has approximately nil propects of succeeding with her complaint. Her claims over the years have not only made her a public figure in the United States, but also internationally. Thus, she has to prove malice, which would mean that she would have to prove Dr Offit and Wired knew that his assertion was untrue when he made it. In this situation, that’s an all-but-impossible mountain to climb.

Having lived for so many years under the protection of the first amendment, I suspect that it will now come back to bite Ms Fisher, and her lawyers, in the ass.

This isn’t like Paul Offit changing a few words in his excellent book for the benefit of Mr Handley. Wired simply couldn’t cave in over a first amendment issue. Their very sense of themselves would be at stake. I suspect their lawyers will let it run for awhile, and then hit the other side with a massive bill for costs.

Certainly, that’s what happens in the UK, and we don’t even have a first amendment.

My own stringent ad hoc research as a non scientist has failed to find (out of three million individuals) any single example of an autistic person.

Hi, i’m just over from England. We have a village missing an idiot. He answers to the name of Tony. If you see him, can you give him a nice cup of cocoa and send him back please. Be kind, he scares easily.

I was wrong because I was quoting from memory instead of looking up my reference, so it’s a good thing no-one paid any attention. The number of antigens in vaccine has dropped 96% since 1960, when we used a whole-cell vaccine against whooping cough (pertussis). If you’ll go to my URL on this comment, you’ll find a graph the antigen load from vaccines since 1900.

@Monado: I read your comment but the wording had puzzled me and I was going to ask about it but then found your clarification at 82 so don’t need to now.

@Anna: I’ll give you a few short answers to your questions. However, if you want full answers, you will have to either use Google or the search on Sciblogs or Science-Based Medicine. I don’t have time at work to give long answers.

1. Long term studies (multiple please) of our vaccination program All vaccines are under long-term studies, since we monitor for adverse events. Even though VAERS is voluntary, it is a good starting point.
2. Studies comparing health outcomes of vaccinated versus unvaccinated Unethical, except as a retrospective. The Genevea Convention forbids denying people the usual standard of care, which is vaccines. You can’t compare populations of vax vs unvax in any balanced study.
3. Studies on combination of vaccines since that is how we give them Again, this is how vaccines are always studied. New vaccines are ADDED to the current schedule, so if any adverse effects are seen, the schedule can be modified or the vaccine removed/altered. As for combination vaccines: Most vaccines started out as single antigen. They were combined decrease the number of shots a child needed and improve compliance. I don’t know about you, but I’d rather get the DTaP as 1 shot over 3 separate ones.
4. Studies that include real placeboes (not another vaccine) Again, see #2; this is unethical.
5. Unbiased studies with independent researchers You find the money for this. It isn’t cheap. And who would you accept as an independent researcher? You need someone who knows how to do research and meet the requirements of an IRB. There are NO independent researchers in the world.
AND last but not least
6. Studies on the possibility of vaccines causing autism.(more than just one ingredient and one vaccine please) What vaccine? What ingredient? Remember, studies have been done BASED on the current vaccine schedule, and there is the recent Italian study that compared 2 different amounts of thimerasol in 1 vaccine and found no differences, and the (?Polish – I forget) study that looked at comparing children who got the MMR vs just the measles vaccine and found no differences.

MI Dawn already got some of the answers I was going to give, but here’s my shot:

We on the pro-vaccine safety side would like to hear some responses to the real argument at hand – the missing science.

First off, define “safe” vaccine. Should they have absolutely no risk? If some risk is okay, what rate (1 per 1 million? 1 per 10 million?).

that there isn’t the money for [the “missing” science]

Resources are certainly limited. Money spent on looking for some purported link (can you provide the missing science that there is a link at all?) takes away from money spent on other areas of research, such as other likely causes of autism (e.g., genetic).

1. Long term studies (multiple please) of our vaccination program

The manufacturers are required to conduct post-marketing surveillance studies, meaning they look at the effects long-term. The CDC and AAP also review the vaccination program every year to revise the recommended schedule. They examine the science and data that have come out over the years, including new data within the most recent year.

As MI Dawn said, and as addressed already here and at Science-Based Medicine, a prospective trial involving actively giving or not giving vaccines to children would be grossly unethical. Please read the Belmont Report and the Declaration of Helsinki, which govern human trial ethics.

3. Studies on combination of vaccines since that is how we give them

Every new vaccine that comes out is tested in combination with the current schedule, since the majority of the population receives vaccinations already. Some even undergo testing to evaluate the effects if given simultaneously. Take a look at the insert for Merck’s MMR-II vaccine. It is strongly recommended that companies test for drug-drug interactions if it is likely that their product will be given concomitantly with another drug (i.e., unless they present a very good reason why they did not conduct such an evaluation, FDA will most likely not approve it).

4. Studies that include real placeboes (not another vaccine)

As cbe mentioned, there are placebos that are not another vaccine (which, by definition, are not placebos to begin with). In fact, early-phase clinical trials (e.g., Phase I or II) for new products almost always test against a placebo to determine if there actually is any effect. Those studies are done before the product is even approved for marketing.

5. Unbiased studies with independent researchers

Please define “unbiased” and “independent”. If you mean “not funded by industry”, that’s not good enough, as not all industry-funded research is biased and not all research free of industry funding is unbiased (just look at some of the Geiers’ studies for an example of biased, non-industry-funded “research”). There are actually rather strong regulations about conflicts of interest, at least where new medical product approval is involved.

6. Studies on the possibility of vaccines causing autism.. (more than just one ingredient and one vaccine please)

I would like to see these, too. So, Anna, where are the studies showing that vaccines could possibly be a/the cause of autism? We haven’t seen any yet. Where are the studies that suggest we should even be examining vaccines as a possible cause? Where are the studies that single out vaccines as a possible cause over, say, changes in awareness, outreach and diagnostic criteria? Or over genetic links? Or over age of conception? Or over vitamin deficiencies? Or over increased use of the internet?

Quick pop in. @Todd W: Oops…Thanks for the correct info. I meant Declaration of Helsinki, not Geneva Convention (that has to do with treatment of POWs, right?). Blame it on quick typing. My nordic sister would be ashamed of me.

Clarification for Anna: I think she means the vaccination schedule in its totality. An child born in the US *usually* receives a Hep B shot before discharge. They are vaccinated again at 2 months. Again at 4 months. Again at 6 months. Again at 12-15 months, etc.. etc.. This practice has not been studied and the only means for justifying the addition of vaccines in this manner (and in combination form) is the theoretical capacity of the immune system.

Vaccine studies typically cover only whichever vaccine is going to market, and usually against another approved vaccine (or reactive placebo) as the control. There is no science that addresses the vaccination schedule in its totality. If so, please cite it. I’m very anxious to read it.

MI Dawn:

I think it’s interesting that you think it’s unethical to use a bona-fide control group. Using a vaccine or a reactive placebo is problematic in that it does not give an accurate assessment of adverse events.

Second, adverse events are not recorded. Surely, we (and Wonder Woman) can all agree that the current system used for tracking adverse events is poor, at best. I’d be apt to agree with everyone’s assertion that reactions are rare if we didn’t have such ridiculous reporting system. Why aren’t vaccine defenders, and vaccine refusers alike, rallying together for something like that? It would quickly dismiss either party’s notion that reactions are either rare, or under-reported. The CDC states reactions are under-reported. Are they wrong? Or are we simply ignoring them by leaving it up to the parent to determine whether their non-verbal infant is having a reaction?

Children that cannot tell you they are experiencing a reaction seem to be the wrong group to be vaccinating since there’s no way to track adverse events.

Quote: “(e) Postmarketing studies. (1) Licensed manufacturers are not required to submit a 15-day Alert report under paragraph (c) of this section for an adverse experience obtained from a postmarketing clinical study (whether or not conducted under a biological investigational new drug application) unless the licensed manufacturer concludes that there is a reasonable possibility that the product caused the adverse experience.”

I’m not particularly fond of leaving the manufacturer in charge of determining whether a product they will profit from results in an adverse event.

And, they can apply for waivers so they don’t have to report them if:

Quote: (1) An explanation why the licensed manufacturer’s compliance with the requirement is unnecessary or cannot be achieved,

(2) A description of an alternative submission that satisfies the purpose of the requirement, or

(3) Other information justifying a waiver.

(b) FDA may grant a waiver if it finds one of the following:

(1) The licensed manufacturer’s compliance with the requirement is unnecessary or cannot be achieved,

(2) The licensed manufacturer’s alternative submission satisfies the requirement, or

Clarification for Anna: I think she means the vaccination schedule in its totality. An child born in the US *usually* receives a Hep B shot before discharge. They are vaccinated again at 2 months. Again at 4 months. Again at 6 months. Again at 12-15 months, etc.. etc.. This practice has not been studied and the only means for justifying the addition of vaccines in this manner (and in combination form) is the theoretical capacity of the immune system.

Please provide your evidence that “this practice has not been studied” and is not justified.

Vaccine studies typically cover only whichever vaccine is going to market, and usually against another approved vaccine (or reactive placebo) as the control. There is no science that addresses the vaccination schedule in its totality. If so, please cite it. I’m very anxious to read it.

This is false. Are you REALLY asserting that vaccine testing somehow magically conjures up a group of otherwise unvaccinated individuals to serve as test subjects? New vaccines are tested in the context of the existing vaccine schedule. Citation: every single vaccine study that has ever been performed.

I think it’s interesting that you think it’s unethical to use a bona-fide control group. Using a vaccine or a reactive placebo is problematic in that it does not give an accurate assessment of adverse events.

You misunderstand. When testing a single new vaccine, the control group is indeed given a placebo (typically saline). What’s grossly unethical is a study where some individuals would not receive currently established vaccinations; the reason should be obvious. You simply can’t deliberately expose test subjects to the risk of contracting deadly diseases for research, when there are well-established and thoroughly tested (and standard of care) protections from them.

Second, adverse events are not recorded. Surely, we (and Wonder Woman) can all agree that the current system used for tracking adverse events is poor, at best. I’d be apt to agree with everyone’s assertion that reactions are rare if we didn’t have such ridiculous reporting system.

Think this through a bit. It’s made so easy to report adverse reactions that The Hulk and Wonder Woman can get in, and this somehow implies that adverse reactions AREN’T reported?

Signal-to-noise ratio is less than perfect, admittedly, but claims that adverse reactions aren’t carefully tracked are simply false.

Did I read your statement correctly? You want me to provide you evidence that the CDC recommended vaccination schedule, it its cumulative practiced form, hasn’t been studied? I think the stance that vaccine refusers tend to take, is that you first study it before adopting it universally. I think it’s a bit backwards to assert something as safe, and then tell me to prove a negative.

Perhaps I was confusing when I was addressing control groups. I did not assert anything regarding unvaccinated people, that has its own problems / limitations. Of course, both groups would be very similar in their vaccination status. However, giving one group one vaccine and another group a different one (or a placebo with an adjuvant) tells us…. dunno? What’s it tell us?

Are you really telling me that when vaccine trials begin that the control group is given a saline placebo? Maybe I’m looking in the wrong place, would you be kind enough to direct me?

As to VAERS… it’s close to worthless, IMO. Yes, I assert that reactions are, on the whole, not reported and the system is subject to abuse. Besides, people don’t even talk about reactions. Others refuse to acknowledge the possibility. I read a vaccine package insert that stated that the vaccine recipients recorded their OWN adverse events on diary cards for 14 days post trial. Surely we can agree that as shoddy reporting system does nothing for this discussion?

This practice has not been studied and the only means for justifying the addition of vaccines in this manner (and in combination form) is the theoretical capacity of the immune system.

Citation please that the practice has not been studied. Citation that the justification is only the theoretical capacity of the immune system. As far as the spacing of boosters, that is based on real data, not theoretical ideas. Clinical trials generally examine several different schedules and dose levels to determine which gives the best immune response in the greatest number of individuals (e.g., too close in time or too far apart and efficacy diminishes, too high a dose or too close together and adverse reactions might increase, etc.). You may also wish to contact the CDC or AAP to ask them how they determine the schedule. The AAP has a FAQ explaining why the schedule is the way it is, available here

Vaccine studies typically cover only whichever vaccine is going to market, and usually against another approved vaccine (or reactive placebo) as the control.

Citation needed. BTW, if a control is reactive, then it is not a placebo. It is an active control. See cbe’s post listing saline as placebo controls above.

There is no science that addresses the vaccination schedule in its totality.

So it is your contention that whenever a new vaccine is added to the schedule or comes to market, that the investigators purposefully withhold all vaccines other than the comparative controls (active or placebo) from all of the individuals in the study? In other words, if they are testing a new vaccine for, say, strep throat, they would ensure that all individuals enrolled in the trial do not receive any other vaccine on the schedule (e.g., HepB, MMR, DTP, etc.)? In a random sampling, individuals who would be up to date with their immunizations would be well represented in both the investigational arm and the control arm(s). Therefore, any adverse events as a result of the investigational vaccine would be found.

I think it’s interesting that you think it’s unethical to use a bona-fide control group.

The problem is not using a “bona-fide” control group for a new vaccine. The ethical problems arise when you are trying to do an experimental study comparing those receiving vaccines (either complete or partial schedule) vs. those receiving absolutely zero vaccines. The zero-vaccine group is being placed at significant risk of serious injury or death from preventable diseases. Those risks are much higher than the known and even speculative risks from the vaccines.

Second, adverse events are not recorded.

Yes, they are. Manufacturers are required, by law, to gather (through post-market surveillance) and report adverse events associated with their products, even if there is no clear causal connection. Others (physicians, nurses, patient) can voluntarily report AEs. That’s a flaw in the system, I think, and where the under-reporting comes from. Health care workers should be required to report all AEs.

There is under-reporting because not all individuals who would learn about AEs and be capable of accurately reporting them are required to do so. On the flip side, a lot of reported AEs turn out to have nothing to do with the product, but are merely coincidental. More serious AEs are more likely to get reported in VAERS, though, than minor AEs (like itching), since individuals who experience more serious AEs are more likely to seek treatment. If there is underreporting, then, it is more likely that the majority of unreported AEs are minor.

At any rate, the reporting regulations do need to be revised to be more stringent. FDA also needs to get more resources to actually enforce those regulations, as well as to investigate the reports that come in to determine whether there really is a causal connection or not.

Actually, the post marketing surveillance is also subject to regulatory circumvention. Title 21 CFR (sorry I’m html challenged when it comes to placing links, they never work)

Read a bit more carefully. The bit you quoted only exempts manufacturers from issuing a 15-day alert to FDA in the context of a post-market surveillance study. The AE still needs to be reported in periodic reports, as well as once the study is completed and submitted to FDA.

As to the waivers, note that manufacturers must submit supporting evidence that shows why they either should not be required to comply with the specific regulation, or that they cannot comply with it. Also be aware that FDA can tell the manufacturer that what they provided to support their waiver doesn’t cut it and that they either need to comply or face regulatory action.

I think what Cynic is saying is that while the MMR or varicella vaccines are tested there are no tests measuring how children react to multiple same-day vaccinations – as in the case of this mom at circleofmoms.com:

I can’t even remember everything she got but I think she possibly got the menangitis shot, a Rotavirus shot, the Diptheria, Tetnus, Pertussis combination and a flu vaccine. One of them was an oral vaccine. I am considering finding a new doctor because this one didn’t seem to make me feel comfortable to express my concerns.

Did I read your statement correctly? You want me to provide you evidence that the CDC recommended vaccination schedule, it its cumulative practiced form, hasn’t been studied? I think the stance that vaccine refusers tend to take, is that you first study it before adopting it universally. I think it’s a bit backwards to assert something as safe, and then tell me to prove a negative.

In light of the fact that all vaccines are subject to the same approval and testing requirements as any drug, the claim that such studies are not done is really quite extraordinary. So yes, if you mean to claim the contrary, the burden of proof is on you.

Perhaps I was confusing when I was addressing control groups. I did not assert anything regarding unvaccinated people, that has its own problems / limitations. Of course, both groups would be very similar in their vaccination status. However, giving one group one vaccine and another group a different one (or a placebo with an adjuvant) tells us…. dunno? What’s it tell us?

Quite a lot. Giving one group one vaccine for a disease and another group another one allows us to evaluate which one is better. Using an injection that includes adjuvants (all of which are well-studied and demonstrated safe before they can be used, again just like any drug) as the placebo allows us to distinguish what effects are specifically due to the antigens in the vaccine.

Are you really telling me that when vaccine trials begin that the control group is given a saline placebo? Maybe I’m looking in the wrong place, would you be kind enough to direct me?

In at least some cases they are; there was list of many such studies in a recent thread here. I’ll see if I can lay my hands on the precise post.

As to VAERS… it’s close to worthless, IMO. Yes, I assert that reactions are, on the whole, not reported and the system is subject to abuse.

When you assert that reactions aren’t reported because it’s too easy to report them, I’m really going to have to demand evidence. The basis on which your claim was originally made is just so outlandish that it deserves ZERO credence without explicit evidentiary support.

I read a vaccine package insert that stated that the vaccine recipients recorded their OWN adverse events on diary cards for 14 days post trial. Surely we can agree that as shoddy reporting system does nothing for this discussion?

The fact that you can claim (with an apparently straight face) that babies shouldn’t be vaccinated because they can’t tell you when there’s an adverse reaction, but then object to asking recipients to record any reactions, is really quite hilarious. Self-consistency is apparently not a big concern of yours, I take it?

The oral one would be the rotavirus vaccine. Since rotavirus attacks the gut, the oral route provides the best defense.

I’m not sure it’s true that vaccines are not tested in the form of being given at the same time as others. I don’t know much about how the actual trials are administered. If the manufacturers recruit doctors to provide the vaccines (with proper informed consent and such) to patients, then odds are, they’re being administered in conjunction with other vaccines. If, however, the manufacturers run their own private clinics, it’s unlikely other vaccines would be administered at the same time for reasons of simple practicality.

Personally, I’m comfortable letting post-market surveillance look for problems with that, since it seems so unlikely that problems would occur. But I can understand others not sharing that comfort level. I don’t have a good answer for it, though.

Sid’s example brings up a related, but separate issue: the difference between vaccine safety when used in conjunction, and doctors following the instructions for use. If doctors aren’t following the instructions for use (I haven’t looked at the inserts to see if there’s anything in the warning, indications or contraindications sections of any those, btw), then any injury is not necessarily the fault of the vaccine, but rather the fault of the doctor not following instructions.

It’s like saying that it’s the forklift’s fault that someone got hurt when the operator took a nighttime cold remedy before operating the forklift.

Well said. That’s something that jen also brought up in that other thread last week — that there are indeed examples of doctors/nurses not giving the vaccines in an ethical way. Sloppiness. For instance, vaccinating a sick kid. It happens. It’s not consistent with the standard of care, but it happens, and people need to let someone know when they see it happening, because the system really depends on patient complaints to determine when someone’s misbehaving.

You have to register with Pulse Magazine, then you can search their archive. The srticle in question featured as a news item, and was reported as I quoted it (but I have not quoted all of it – copyright etc.)

It is clear the researchers saw the confounding for what it was, and everyone agreed the link was NOT causal, but appears because those who visit the doctor are more likely to be vaccinated as well as more likely to be diagnosed with an illness such as asthma. In addition, asthmatics are more likely to be put forward for vaccinations, so as to avert respiratory infections.

Bateson (like antivaxers, creationists, AIDS-deniers) just keeps parroting the same old stuff even when he knows it is quite misleading and he is happy to give people the wrong impression (that there is a causal link). That is quite scandalous, and tantamount to lying (by omission of the truth).

My contention is that vaccination status should obviously be as consistent as possible in both groups for any meaningful results. In an experimental trial, I’m not sure you can say the ‘preventative’ measure is placing the zero group at risk. They aren’t ‘life saving’ until proven so.

We obviously agree on portions of the reporting problems. As to being more complicated than I think? This begins with some fairly loose language in the code, not with my interpretation. In all practicality, if a vaccine maker has applied for a waiver for a particular vaccine, this is information that the practitioner should be aware of and provide consult on and it should be in the circular. Record retention and collection is a bit of an issue also.

Scott –

Adjuvants are not inert substances and they provoke immune response (regardless of the definition of ‘safe’). It is certainly possible that some subsets of people don’t tolerate the exposure as well as others. Using a substance that ALSO elicits an immune response can make it difficult to determine the validity of the adverse events that DO get reported during trials.

I’m unclear on your necessity for ridicule of my remarks. Be that as it may, you seem to either be trapped finding a way to demonize my point of view based your perception of my character, or unclear why the general public is having a harder time with provaccine arguments. Either way, let me see if I can try again:

1) Adverse reporting is essential in the analysis of risk / benefit, because for normal citizens, this isn’t all about money. If we are able to accurately determine that there are 7000 reactions to the chicken pox vaccine every year and roughly 250 people suffer “severe” reactions – when compared to those actually getting the disease and suffering harm or death… seems like more risk involved in the vaccine (this is a common argument those tracking VAERS reactions make). An older toddler can tell you that their brain hurts and feels like it’s going to explode out of their head, a non-verbal infant cannot.

2) Leaving the reporting up to the individual in an uncontrolled setting is apparently better? My realization of the problems in our absurd reporting system results in my hilarity and degradation of self consistency? This is either total tunnel-vision, or you are incapable of civil exchange.

I strongly encourage the skeptical community, and all of its followers, to really think about the way they engage people that are trying to understand this issue.

The fact remains (pursuant to my original post) that there is not a single study, that has covered the *ENTIRE* CDC recommended schedule in its totality. And, if we are prepared to say, that the infant immune system is well understood, and that repeated vaccination during certain time periods of development, is causing no harm… and have the science to prove it, people will stop telling you that we’ve got “too many shots too soon”. What has been furnished to date, is not convincing. You’ll need to do better, and it starts with less ridicule and more substance.

The fact remains (pursuant to my original post) that there is not a single study, that has covered the *ENTIRE* CDC recommended schedule in its totality. And, if we are prepared to say, that the infant immune system is well understood, and that repeated vaccination during certain time periods of development, is causing no harm… and have the science to prove it, people will stop telling you that we’ve got “too many shots too soon”. What has been furnished to date, is not convincing.

Four words: “Moving goalposts” and “null hypothesis.”

Has the “*ENTIRE CDC recommend schedule in its totality” been proven beyond a shadow of a doubt to be safe? No, but neither has anything else. Just three things off the top of my head that I’m more worried about for my son than vaccines: Ultrasound, BPA and other EDCs, the white noise generator we use in his room. All of those (except maybe the BPA) are *probably* harmless, but there have been small-scale studies suggesting a potential effect, and the safety has not been well studied for any of those — not even close to as well studied as vaccines.

If you worry about every single thing that hasn’t been exhaustively studied with an RCT for every possible permutation, you can’t leave the house.

Adjuvants are not inert substances and they provoke immune response (regardless of the definition of ‘safe’). It is certainly possible that some subsets of people don’t tolerate the exposure as well as others. Using a substance that ALSO elicits an immune response can make it difficult to determine the validity of the adverse events that DO get reported during trials.

No, actually it makes it easier. You can readily distinguish between adjuvant reactions and vaccine reactions; given that only the latter is new this makes good sense.

I’m unclear on your necessity for ridicule of my remarks.

When your “remarks” are grossly wrong-headed, expect to be called on it.

Be that as it may, you seem to either be trapped finding a way to demonize my point of view based your perception of my character, or unclear why the general public is having a harder time with provaccine arguments.

Please point to where I’ve indicated any such thing.

1) Adverse reporting is essential in the analysis of risk / benefit, because for normal citizens, this isn’t all about money. If we are able to accurately determine that there are 7000 reactions to the chicken pox vaccine every year and roughly 250 people suffer “severe” reactions – when compared to those actually getting the disease and suffering harm or death… seems like more risk involved in the vaccine (this is a common argument those tracking VAERS reactions make). An older toddler can tell you that their brain hurts and feels like it’s going to explode out of their head, a non-verbal infant cannot.

You have still to explain how over-reporting of reactions results in under-reporting of reactions. As this is apparently the key point of your claim, and is on the face of it beyond ludicrous, your continued silence on the matter is quite perplexing. Unless we assume that you DON’T have any actual understanding of the subject.

2) Leaving the reporting up to the individual in an uncontrolled setting is apparently better?

Your “evidence” doesn’t indicate that such reporting was all that was done, only that it was done. Effectively, you have claimed that it is a bad thing to ask recipients to keep track of reactions. That is facially ridiculous and grossly inconsistent.

If you intend to claim that such is the ONLY form of reporting, you must provide evidence for such.

My realization of the problems in our absurd reporting system results in my hilarity and degradation of self consistency?

When you don’t actually realize any of the REAL problems in the system, and instead claim the exact opposite of what your own arguments clearly imply, yes. That’s quite hilarious and not at all self consistent.

This is either total tunnel-vision, or you are incapable of civil exchange.

I don’t see how anyone could legitimately claim I’ve been at all uncivil to you, unless the standard of civility is slavish deference to illogical arguments.

I strongly encourage the skeptical community, and all of its followers, to really think about the way they engage people that are trying to understand this issue.

The fact remains (pursuant to my original post) that there is not a single study, that has covered the *ENTIRE* CDC recommended schedule in its totality.

Aside from the ones that evaluated adding the newest vaccines to it. IT’S BEEN DONE.

And, if we are prepared to say, that the infant immune system is well understood, and that repeated vaccination during certain time periods of development, is causing no harm… and have the science to prove it, people will stop telling you that we’ve got “too many shots too soon”.

We are, we do, and they don’t.

What has been furnished to date, is not convincing.

It is entirely convincing to those with some understanding of the science. The fact that some celebrity idiots without any comprehension of facts or science choose to ignore it and attempt mass murder of infants, while regrettable, is not a failing of science.

My contention is that vaccination status should obviously be as consistent as possible in both groups for any meaningful results.

A large, properly randomized study will have treatment and control groups that should have roughly similar vaccination statuses. Some trials may be more focused and explicitly include/exclude based on which vaccines have been received, but such a trial is not only more time and resource consuming than one without such criteria, it also does not reflect the real world. While such a study might find a statistically significant effect, the next question is this: is that effect clinically relevant?

In an experimental trial, I’m not sure you can say the ‘preventative’ measure is placing the zero group at risk. They aren’t ‘life saving’ until proven so.

If we do a study examining the current, approved schedule of vaccines (or some subset thereof) compared against zero vaccines, the individuals in the zero vaccine group are at risk. We know that the diseases prevented cause specific injuries at given rates. We know that the vaccines prevent infection. We further know the adverse events causally related to the vaccines and their rates. These things have been shown through not only clinical and post-marketing trials, but epidemiological and similar studies. Therefore, if we have a known standard of care that prevents illness, along with its serious complications, and we know that the risks of those illnesses and complications is greater than the risks of the standard of care, then it would be unethical to no provide that standard of care to study participants.

Here’s an example. We have a new cancer drug for the treatment of prostate cancer. Prostate cancer is a rapidly progressing disease for which delay can mean a huge difference in outcome. In studying the new drug in prostate cancer patients, it would be exceedingly unethical to provide a placebo as the control, rather than the standard of care. Just like you are putting the cancer patient at greater risk of irrevocable progress of their disease, you put individuals at risk of irrevocable infection, along with its attendant complications, if you do not provide access to immunization.

As to being more complicated than I think? This begins with some fairly loose language in the code, not with my interpretation.

Actually, your interpretation does have a bit to do with it. Circumventing adverse event reporting isn’t easy. Could it be done? Possibly, but it would be rather complex and, when the perpetrator is caught, seriously detrimental, not only from FDA sanctions (including criminal charges, if warranted), but also from PR. It’s not worth it. As to “loose language”, to which language are you specifically referring? Laws are pretty loosely worded so that the regulators can adapt to situations not anticipated by the lawmakers. That’s where regulations come in. Regulations are much tighter than laws (e.g., the difference between 21 CFR and the FD&C Act). Regulations do carry the weight of law, though. There is also legal precedent (also carrying the weight of law). On top of all that, there are also guidances issued by the FDA. These reflect the agency’s current thinking on some issue. While they don’t carry the weight of law, good luck ignoring them. FDA generally does not approve something that goes against or ignores a guidance, unless the manufacturer can provide some really good reasons why the guidance should not apply. Even then, the FDA may reject their reasoning.

An older toddler can tell you that their brain hurts and feels like it’s going to explode out of their head, a non-verbal infant cannot.

They can make their discomfort apparent, though. Such a reaction is something that would come up in clinical trials. Hence why we know the relative risk of encephalitis for certain vaccines, a risk which is much lower than the risk of encephalitis from the disease (e.g., measles). In the post-market world, we are somewhat beholden to parents to actually take their kid to the doctor when they show such a level of (presumably constant) discomfort, and for the doctor to be decent enough to actually try to figure out what’s wrong. Are there docs that wave their hand and say “that’s expected; it’ll go away”? Yep, but there are also those who take the time to do due diligence. Rarely, some new, unknown AE pops up. It might be unrelated, might not. If it continues to pop up, suggesting a trend, then FDA may require the manufacturer to do a study specifically looking at that AE. Depending on the severity, the product may or may not be suspended from market. Often, the case will be that it is either unrelated, or it happens so rarely as to warrant making note of the risk, adding it to the labeling, but remain far and away inconsequential in terms of the overall safety profile vs. the disease.

Todd W.
“… we are somewhat beholden to parents to actually take their kid to the doctor when they show such a level of (presumably constant)discomfort, and for the doctor to be decent enough to actually try to figure out what’s wrong. Are there docs that wave their hand and say, “that’s expected, it’ll go away?” Yep, but there are also those…”
You just said a MOUTHFUL!!! Parents repeat that story ALL THE TIME!

Combine that with what Calli said, “there are indeed exapmles of doctors/nurses not giving the vaccines in an ethical way,” and you’ve got potential for serious problems.

The CNS development that occurs in the first two years of life are rather critical and I dare say that NO ONE fully understands it. The infant immune system is also far from fully understood (and should NEVER be compared to adolescents or otherwise… Hep B comes to mind). I’ll admit I’m a little mind boggled that you’d suggest such a thing. No offense, but it’s a little bit arrogant too.

Magnetic resonance imaging has shown that myelination in the brain occurs well into the second year of life. Longer even. The BBB is certainly not fully understood, and definitely NOT fully formed at birth. There are numerous avenues that make infants susceptible, not just infectious disease. I am not making claims regarding either (before the debate tactic accusations begin again) simply saying that the broad statement you made is just not true. Or not as true as you’d like it to be.

And no, Scott and James Sweet – the cumulative effects of the CDC recommended vaccination schedule on the growing human infant have not been studied. We’ve got no problem vaccinating at 24 hours, 2 months, 4 months, 6 months, and so on and so on. Safe until proven otherwise? Wrong. I’m not here telling people it’s safe because I’ve compared this vaccine to that vaccine, or this vaccine to this adjuvant. All in vaccinated people without an observational study on vaccinated and unvaccinated people to see if there may be detrimental effects. You are.

As to the civility of your posts Scott… if you say so. I’m not particularly fond of ridiculing other people, be it their character or otherwise. It simply shows you are incapable of engaging someone that would have legitimate questions on the topic in a civilized manner. See that sitemeter at the bottom? How many of those millions are regular moms and dads that came here because they were steered here from a parenting board? If they were to question the ideals contained here (or watched others be descended upon), and then told that their observations were “hilarious” or sarcastically told that “self-consistency isn’t a big concern for you” while they are trying to understand this issue, they might flip you the bird into their monitor and go elsewhere. If persuading those that disagree with you, and disseminating misinformation is truly the purpose of the comments here – you’re missing the target. This is probably where you accuse me of “concern trolling”… And it would be fitting I suppose because I don’t normally post here. But that doesn’t mean I don’t read, and this is precisely the point.

Your last sentence is pure sensationalism, and I’m not sure how that furthers discussion.

Scott,

Thank you again for you your response. The loose language I am referring to are definitions for the words “safety” and “purity”:

(p) The word safety means the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.

(r) Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances.

Ambiguity at best. Ripe for abuse. A good example of regulatory ‘looseness’ is the Federal Food, Drug and Cosmetic Act that handles the process of commercial animal feed. Obviously not the same as biologics, but the FDA nonetheless. This kind of language does not belong here.

My issue with waivers, are that you should positively not be able to produce a biologic that is then mandated for universal use, and then get a pass on the rules. Period. This is obviously a highly polarized topic and with regard to the law, the meat of the subject (for me at least and by no means do I speak for everyone) resides in the intended use of the product. Since there are people that feel that others should not be able to choose whether or not to vaccinate themselves or their children, then loopholes should not exist… at all. Loopholes get larger when you apply other misdeeds from the same manufacturer for some other drug.

cynic, you are not furthering the discusion. Visiting a point that has been answered again and again and again regardless of whether you happen to be knowledgeable of it and constantly saying ‘stop being a meanie’ will only earn you hate from a community that’s been dealing with this for sometime now.

Judging from your posts directed at scott as well as your quote mining, you really are a troll. I’m almost positive but since it’s a new year and I’ve resolved to give people the benifit of the doubt, I’ll advise you to look up what Orac has said about this topic before and follow the links he’s provided to others knowledgable on the subject. And I will also remind you that an argument stands on it’s own two feet regardless of how often an insult is thrown around. That some chooses to insult their opponent does not make them wrong. It just speaks to their frustration with the topic.

Someone with a proper open mind can see that. Again, someone with an open mind can see that and look past their bruised ego for 5 seconds.

According to the complaint in the case provided by Steve Novella and quoted above, her suit is in Federal Distict court, not the Virginia state courts. It is not clear why she is quoting a Virginia statute as juridictional for the Federal court, since all she has to show is “diversity of citizenship” (all defendants come from different states than the plaintiff) and that the suit involves a claim in excess of $50,000. The question of which state’s law (if any) will be applied is a complicated determination that will be made by the court but not based solely on the state that the Federal court happens to be in.

From this lawyer’s perspective, her suit is laughably weak (something I’ll have a post up about shortly at my above blog) but, even worse, the only remotely colorable claim is that Offit damaged her business of opposing mandatory vaccination. That is, she is not running her National Vaccine Information Center as a truly non-profit organization but as a money-making proposition.

“Like the Amish, like the Homefirst community there are no autistic people in Britains unvaccinated.”
I have written up a couple articles trouncing Olmsted. My major conclusions were that he didn’t understand the Amish/Mennonite/Amish-Mennonite culture, and got the substance of his stories from interviews with a few alt health people. Even then, he didn’t actually claim there were no autistic Amish, and even admitted to being aware of unvaccinated autistic Amish. Interestingly, he even reported one unvaccinated autistic from the Texas Amish, who number fewer than 150.

NVIC is a non-profit. Brings in roughly $300K per year. BLF makes about $40k per year in salary and is the company’s only full-time employee. Rest of the spend is mostly “program services”, which I assume is the money the NVIC spends convincing people that vaccines are evil.

So you would opt for stricter definitions of “safety” and “purity”? Pray, tell, what would those definitions be that would satisfy you? Remember, the definitions need to be able to be applied to everything from band-aids and cotton swabs to treatments for fatal, rapidly-progressing diseases.

Also remember, that in medicine, safety is always relative. It is the comparison of the benefits to be received vs. the risks incurred (both from the product and from the condition the product treats). Likewise, the level of acceptable purity can be different (e.g., an IV product has a higher relative purity requirement than the purity of materials in a diagnostic device).

So, enlighten us how you would change the definitions to prevent abuse while not placing unreasonable burdens on the wide variety of products manufactured. Further, could the ambiguity in the regulation be covered by guidance documents from the agency specific to the product in question (e.g., one set of guidelines for a band-aid, a different set for a pancreatic cancer drug)?

The CNS development that occurs in the first two years of life are rather critical and I dare say that NO ONE fully understands it. The infant immune system is also far from fully understood

I’m going to have to call goal post shifting. Your original claim was

the infant immune system is well understood, and that repeated vaccination during certain time periods of development, is causing no harm

And now you’re demanding complete understanding (far more than “well” understood) of the immune system AND CNS development?

Not only does such shifting indicate either dishonesty in argument or poor understanding, it’s not a relevant bar. The relevant bar is “do we understand well enough to have confidence in the safety” – which is definitely YES.

I’ll admit I’m a little mind boggled that you’d suggest such a thing. No offense, but it’s a little bit arrogant too.

A cursory reading will demonstrate beyond a shadow of a doubt that I never said anything even vaguely similar to that which you impute. Either you’re being very sloppy, or you’re deliberately lying.

I am not making claims regarding either (before the debate tactic accusations begin again) simply saying that the broad statement you made is just not true. Or not as true as you’d like it to be.

The broad statement I made IS true. The orders of magnitude broader statement you chose to make up is not.

And no, Scott and James Sweet – the cumulative effects of the CDC recommended vaccination schedule on the growing human infant have not been studied. We’ve got no problem vaccinating at 24 hours, 2 months, 4 months, 6 months, and so on and so on. Safe until proven otherwise? Wrong.

You still have not provided the faintest basis for your assertion. It has been repeatedly pointed out to you that this is PRECISELY the context in which ALL vaccine safety studies take place; you have never responded to this.

As to the civility of your posts Scott… if you say so. I’m not particularly fond of ridiculing other people, be it their character or otherwise. It simply shows you are incapable of engaging someone that would have legitimate questions on the topic in a civilized manner.

I’ll grant that “Self-consistency is apparently not a big concern of yours, I take it?” was a bit snarky, and I apologize for that one. But it does not even come vaguely close to personal ridicule. And referring to ludicrous arguments as “hilarious” cannot possibly be considered offensive by any reasonable person.

That you would claim it to be so indicates to me that either (a) you’re so completely unused to having your assertions questioned that you take it as a personal attack or (b) you’re falsely claiming such offense in order to distract attention from your complete failure to provide any support for your assertions.

Your last sentence is pure sensationalism, and I’m not sure how that furthers discussion.

It’s purely and strictly factual, and I firmly believe that keeping the stakes squarely in the front of the debate is crucial to discussion of antivax idiocy. If you’d prefer to ignore the fact that if the McCarthys and Handleys of the world get their way, it will very literally kill millions of babies – well, I prefer not to permit that.

You are free to pick apart debate tactics, it appears to be the best position of those defending “science” (and all that this entails). This is the reason I don’t post, I’m not alone in that either.

You are also free to insinuate I shifted the goal posts Scott – are you telling me that the nervous system plays no role in the host’s ability to fight infection – what happens when the immune system attacks the nervous system? Are you also telling me that the blood brain barrier (a pesky part of neuroscience when you’re trying to administer drugs to the brain) plays no role in protecting the host? The immune system is rather complicated, in my view, and many parts of the body operate in concert to protect any single organism from harm. Vaccine science, while shifts of late to cell-mediated immune response (a concept not even recognized until well after vaccine programs were underway) shows promise, don’t really focus on anything but a humoral response. IE: not fully understood. You are free to disagree.

As for having a “bruised ego” Julian… well, I don’t have an ego actually. And ‘stop being a meanie’ is certainly not what I said, but it wouldn’t be the first time I was misinterpreted or words have been put in my mouth. If you think that a community which boasts itself on spreading truth and is trying to reach those that have been misinformed, is helping matters by condescending opposing thoughts, I’m here to tell you that you’re wrong. I didn’t come in here throwing stones at anyone, and I challenge you to find where I have.

That’s the difference between myself, and the majority of people that post in agreement here. I don’t think talking down to people gets any sort of point across, other than you are unwilling to listen to what other people have to say and engage them thoughtfully. I’m sorry if you feel tired for having done it so many times, some people are approaching this issue for the first time. And after spending countless hours on message boards reading their thoughts, I wish I had a dollar for every post that read that parents left their pediatric practice after their pediatrician ostracized them for even trying to discuss the topic. Perhaps it’s just the way I was raised? If you consider me a troll for popping in and having a “concerning” word or two, also your perogative. You (like myself) certainly don’t have to read or respond to it.

Either you’re being very sloppy, or you’re deliberately lying.

I’m certainly not lying. I just think in longer and more collective terms than most, I suppose. I don’t think we can assess the long term benefits of vaccinating the very young when it’s only been happening for a few decades. I don’t think vaccinating day old newborns using trial data with immunogenicity compared to adolescents is particularly good science either. I also admit that there are some vaccines that I consider to be important, but no one seems to care about the fact that I actually am not “anti-vax”, nor am I “safe-vaccine” (an argument that think is a poor one). Such is life.

Hi Todd W,

So you would opt for stricter definitions of “safety” and “purity”? Pray, tell, what would those definitions be that would satisfy you? Remember, the definitions need to be able to be applied to everything from band-aids and cotton swabs to treatments for fatal, rapidly-progressing diseases.

Very fair questions. These terms allow the escape of quality control, however unintended. I only say this, because I’ve witnessed it in the veterinary community. My example of commercial animal feed stems from ambiguous language in the law. This language allowed, upon further testing, items like, flea collars, plastic, styrofoam, Pbb (administered for euthanasia) etc… in meat meals used for certain commercial feed products. The producers of the product were able to demonstrate that it wasn’t cost effective to remove the food not fit for human consumption from the plastic and styrofoam that they arrived in… nor was it cost effective to remove euthanized animals from the bags, or take off their collars, etc… before entering the rendering vat.

As it relates to the drug industry, and specifically vaccines, this language allows a vaccine maker to demonstrate that it isn’t cost effective to screen cell cultures, or other animal cells for their own viral contamination, or for mycoplasma, or other cross-contaminations. Now we have several aspects of the vaccine production process being outsourced to other companies… and cross-contamination is a very real concern.

As for tightening the language, that won’t happen. The legal arms of the pharmaceutical industry will present monetary evidence and cite global issues for the reasoning. And they’ll win, I’m not naive. This doesn’t alleviate the necessity for more stringent guidelines (I don’t care how much it costs). I really don’t have answers, and I didn’t post to stir up trouble or unnecessary emotion. I’m just trying to show (what I consider) valid reasons that people are skeptical.

This thread is about silencing science-based medicine with litigation… let’s not forget that there are several drug makers involved in litigation that have resulted in harm or death to citizens for not releasing data showing adverse effects from use of their product. These same drug makers also make vaccines – it would be naive to think that there are times when dangers are not fully realized, and then not disclosed for financial gain. Paying out 36 million after your product has made 3 billion seems just like the cost of doing business. Bean counters exist for this solitary reason, in determining when to play the odds.

I will concede that there are extreme, fringe groups in the anti-vaccine camp. I don’t care about those people. I care about the parents that agonize over this decision and are met with animosity for even questioning a practice, or all intents and purposes, is in infancy. If dogs can have anaphylactic responses to miniscule amounts of injected organic substances (sometimes resulting in death) 100 years ago, the same is certainly true of the ingredients contained in any one vaccine. Why people deny this, I have no idea.

If it is contamination you are worried about, you may also want to read this, sec. 501 of the FD&C Act. It covers what is considered adulterated. If current Good Manufacturing Practice dictates that vaccines should be screened for contaminants (which, IIRC, it does), then any product produced in such a way that avoids compliance with those cGMPs is considered adulterated and will not be approved for distribution and marketing.

There is a lot of overlap in the law that helps to close up loopholes like the ones you fear. It’s much more than just one section of law that you cite. So, for contaminants, you have the biologics licensing regs, the adulteration and misbranding regs, the GMP regs, and possibly a few others that I can’t think of off hand at the moment. W

here vaccines are concerned, the screening of possible contaminants became a major concern back when SV40 was discovered to be contaminating the polio vaccine. As a result, manufacturers were required to do more stringent testing to avoid similar problems in the future.

Finally, comparing animal regs to those involving humans is apples and oranges, my friend. Unfortunately, non-human animals are generally not seen as being as important as humans, so there is a lot more wiggle room where animal safety is concerned. It is a problem that should be fixed, but you cannot use examples from animal-related regs to condemn human-related regs.

There is absolutely no possible question that you both hugely shifted the goalposts and grossly misrepresented my comments (deliberately or not). The quotes tell a very clear and explicit picture:

cynic:

And, if we are prepared to say, that the infant immune system is well understood, and that repeated vaccination during certain time periods of development, is causing no harm… and have the science to prove it, people will stop telling you that we’ve got “too many shots too soon”.

Scott:

We are, we do, and they don’t.

cynic:

The CNS development that occurs in the first two years of life are rather critical and I dare say that NO ONE fully understands it. The infant immune system is also far from fully understood (and should NEVER be compared to adolescents or otherwise… Hep B comes to mind). I’ll admit I’m a little mind boggled that you’d suggest such a thing.

As for the reason we’re discussing such things instead of substance – well, it’s because you have consistently refused to provide the requested support for your unsubstantiated assertions. Not much I can do about that.

“if the McCarthys and Handleys of the world get their way, it will very literally kill millions of babies”
If they’d say as much, I’d consider it a step forward. Harcore eugenics is a serious philosophy. All they offer currently is phobias.

“Ironically, in context, the words were actually something of a compliment: “Barbara Fisher inflames people against me. And wrongly. I’m in this for the same reason she is. I care about kids,” Dr. Offit went on.

That contextâand the fact that Ms. Fisher is a public figure, generally expected to take stuff like this on the chinâmakes it unlikely that she’ll be successful in her suit.”

The general impression I get is that expert opinion is not on Fisher’s side. Lets hope she “shot herself in the foot” with this lawsuit and public opinion turns on her.

Jenny’s come close in acknowledging that the diseases would come back. What she hasn’t done is recognized what the consequences of that would be.

I’ll grant that she probably doesn’t really think that mass deaths would happen, given that she seems to believe that vaccine makers could simply snap their fingers and make vaccines “safe” by her standards (which essentially requires them to cure autism and never have side effects of any kind). I’ll even agree that the millions of deaths would never actually happen; once thousands started dying (hopefully sooner) the public would wake up to how stupid the whole thing is.

But if she actually got what she demands – no vaccines that don’t meet her requirements, i.e. no vaccines – there’s absolutely no question that many millions would die as a result. And since those deaths would be due to her stupidity and reckless disregard for facts, that would morally be mass murder even if it wouldn’t reach the legal standard.

Barbara is pretty hot on the right to informed consent. I’d like the right to grant (or, in my case, deny) informed consent to the presence of an unvaccinated-by-choice child sitting next to my kid in school.

Antivaccine lulus everywhere have the right to send their kids to school blissfully carrying whatever (easily and safely preventable) pathogens they like. In 48 states this can be accomplished by getting a religious or philosophical exemption, which is easy to do. In the remaining two states you have to find a quack to write you a medical exemption and come up with a not-too-fake-sounding story.

Where is my right to protect my child against the willfully infectious?

That’s because they are self-centered twits, who have no consideration for anyone but themselves. Vaccination certainly is important for individuals, but the reason the CDC and all medical associations favor it is because it is a public health issue. Vaccination works best when vaccination rates are as high as possible. That serves to protect everyone, because vaccination is not 100% effective, and there are those who are not vaccinated (either for legitimate or non-legitimate reasons). Thus, anti-vaxxers benefit greatly from vaccination programs that have reduced the incidence of disease in the world, but don’t participate in creating that benefit, and, in fact, cause it to be diminish. Yet, they for some reason think those of us who do our part to help protect them, without any reciprocity, should respect their choice. Sorry, assholes, it doesn’t work that way. As members of a society, we all (that means you!) share the responsibility of helping each other.

Now, if they don’t want to participate in the society, I think they have that right. However, that means that they are not allowed participate in any of it. No, you don’t get to use public schools. You aren’t allowed on public transportation, and you are not allowed in a public setting where you interact with participating members of the society, such as the market place. You go out and find a location where you are self-sufficient and not dependent on anyone else for anything. Because if you think you are too special and don’t have to do your part to protect the health of our society, then don’t think for a second that the society should be providing anything for you.

The fact that people like Fisher, Jenny Mc Carthy and her her sidekick comedian partner have managed to thumb their nose at evidence based medicine is saddening. They are nothing but hucksters and snake oil salesmen that prey on a parent’s inherent guilt when their child does not develop normally, even it that guilt is unfounded. Of course when something deviates from the norm a parent will try to find any denominator–no matter how false– to alleviate that guilt. So let’s blame the vaccines.

Of course if we are all frothed up about the evil vaccines, we can be distracted from the fact that the alternative “cures” for autism are the true problem that offer false hope.

Let’s join other huckters and advocate for snakeoil treatments like antifungals, antivirals, oddball diets, expensive supplements that are made by autism awareness organizations and are somehow vastly superior to the exact same vitamins that are have not received teh Autism One or Generation Rescue seal of approval. And then there is the potentially dangerous chelation therapy. While it may be good for lead poisoning for children eating paint chips, there is not one scientific study proving it can “cure” autism.

Do you know what these are? Expensive placebos with side effects!

The antivaccine hucksters are always talking about how Offit, et al have a conflict of interest because they have made a profit. Well what are these snakeoil salesmen doing? They’re making a profit at the expense of parent’s fears. Are they giving away the spendy supplements or chelation therapy. No, they are laughing all the way to the bank. Funny how it is perfectly alright when Jenny McCarthy is the one endorsing the product.

Science has proven that vaccines save lives. Expensive Jenny McCarthy “cures” for autism have done nothing but line the pockets of the hucksters that hawk them to vulnerable families.

In a battle between pseudoscience and anectdotal treatments and evidence based science, I will pick science for myself-and my children–any day of the week.

Thanks to Respectful Insolence for the support in the upcoming lawsuit filed against me by Ms. Fisher. I would point out only that the details of the “settlement” with Mr. Handley are incorrect. Both Mr. Handley and I each agreed to contribute $5,000 to an autism charity of which I approved. (This was my idea). The charity was the Center for Autism Research at UCLA, which, as far as I know, is not Ms. McCarthy’s favorite charity. I assume that Generation Rescue is her favorite charity. Further, Mr. Handley argued with the context, not the accuracy, of his quote in my book. I put the quote in context and wrote a letter simply acknowledging that I had done so. I did not accede to Mr. Handley’s demands of a mea culpa. His case was going no where and he knew it. So he settled for nothing.

So… I have a first edition of Dr. Offit’s book. And now there is a second edition that was released this month.

I went to Amazon dot com to check out the new edition through their “search” function. I found that if I searched for certain things I could read it. I read the new prologue, which was nice. But one page was not available: 145.

I think I know why, and Mr. Handley paid good money to have the words changed. Fortunately Dr. Offit made sure some of that money went to where it could actually be beneficial!